Status:
WITHDRAWN
FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Dorte Nielsen
Collaborating Sponsors:
Danish Cancer Society
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
In this trial chemotherapy regimen FOLFOX with intrahepatic administration of oxaliplatin is combined with immunotherapy (nivolumab and ipilimumab) for the group of patients with multiple liver metast...
Eligibility Criteria
Inclusion
- Informed consent
- Age: 18 - 79 years
- Performance status 0-1.
- Histologically documented colorectal cancer (In case primary tumor has not yet been removed, it should be possible to be removed by surgery)
- Tumor is immunohistochemically microsatellite stable (MSS)
- More than 5 liver metastasis, not eligible for liver resection or radiofrequency ablation (RFA)
- Presence of liver metastasis documented on CT-scan with no documented extrahepatic disease except from primary tumor in situ.
- Measurable disease according to RECIST 1.1
- Involved liver tissue under 70 %
- Perfusion of liver metastasis possible via a. hepatica
- ANC \>= 1,5 x 10¨9/ml og Platelets \>= 100 x 10¨9/ml ,
- Estimated creatinine clearance \>= 60 ml/min
- INR \< 1,4 and bilirubin \<= 1,5 x ULN
Exclusion
- Current or prior second malignancy within 5 years, except from basal cell carcinoma or carcinoma in situ cervix uteri.
- Severe medical condition, such as severe cardiac disease or AMI within 1 year
- Uncontrolled infection.
- Patients positive for HIV, HBV-sAG or HCV antibody
- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of ipilimumab, nivolumab. The following are exceptions to this criterion:
- Intranasal, inhaled, or topical steroids; or local steroid injections (e.g. intra-articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
- Patients requiring treatment with oral prednisolon of dose \> 10 mg daily
- Previous severe, unexpected reaction related to treatment with fluoropyrimidine.
- Previous treatment with oxaliplatin or immunotherapy
- Neuropathy that is contraindicated for treatment with oxaliplatin
- Pregnant or breastfeeding women. Women with childbearing potential (WOCBP) should have a negative pregnancy test and agree to use highly effective method(s) of contraception during treatment and 6 months thereafter.
- Men who are sexually active with WOCBP who do not agree to use highly effective method(s) of contraception during treatment and 7 months after immunotherapy or 6 months after chemotherapy (which period is the longest)
- Patients who, for linguistic, intellectual or cultural reasons, will not be able to fully understand the concept of treatment and respond to any. complications.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04430985
Start Date
September 30 2020
End Date
September 6 2021
Last Update
October 27 2021
Active Locations (1)
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1
Herlev University Hospital, Department of Oncology
Herlev, Denmark, 2730